BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3200224 · Received July 1, 2013

    Report

    Report Number
    9673241-2013-00215
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT:CARTO 3: MODEL# M-4800-01, SERIAL # (B)(4), (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE, THERE WAS A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT. THE PATIENT NEEDED 3 DAYS HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299968 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-03-S 15729400L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R